Individual Follow-up After Rectal Cancer - Focus on the Needs of the Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 336
- 试验地点
- 8
- 主要终点
- Health-related quality of life and symptom burden
研究概览
简要总结
With an increasing number of rectal cancer (RC) survivors, we see a rising attention to the late adverse effects following treatment of RC.
Late adverse effects that are highly prevalent and negatively impact patients' symptom burden and quality of life are: bowel-, urological and sexual dysfunctions; psychological distress; fear of recurrence. The current follow-up program primarily focuses on detection of recurrence, with less attention to late adverse effects.
In a patient-led follow-up program, the surveillance for recurrent disease is combined with detection and treatment of late adverse effects and supportive survivorship care. The follow-up involves a high degree of patient-involvement, aiming at meeting the individual patient's needs.
The patient-led follow-up programme is based on a standardized patient-education in order to enforce the patients to assess and respond sufficiently to symptoms and health problems. In case of symptoms and concerns, the patients are instructed to consult a health professional for adequate assistance and intervention.
The intervention is tested in a multicenter randomized trial, comparing the patient-led follow-up to standard routine follow-up, involving prescheduled outpatient visits.
详细描述
Recruitment:
Patients are included from colorectal surgical departments in Aarhus, Randers, Herning and Aalborg. These centres cover one third of all Danish rectal cancer patients.
Patients are approached at the postoperative visit in the outpatient clinic where they are presented for the pathology results, approximately 2 weeks after primary surgery. The doctor provides short oral information about the study and hand out written information.
Following that, a research nurse makes contact with the patient by telephone a few days later, in order to clarify whether the patient wants to participate or not. Participation requires written informed consent and baseline information from the patient prior to randomisation.
Sample size:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rectal resection for primary rectal adenocarcinoma
- •R0/R1 resection (radical resection of the tumour)
排除标准
- •metastatic disease
- •synchronous cancer
- •not able to understand Danish language
- •severe cognitive deficit, i.e. dementia
- •residual life expectancy less than two years
- •concurrent participation in other scientific studies which affect frequency and content of the follow-up program
结局指标
主要结局
Health-related quality of life and symptom burden
时间窗: Measured at 3 years after primary surgery
Full name: The Trial Outcome Index (TOI), which is a subscale within the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire. Construct: The FACT-C measures health related quality of life. Five subscales can be derived from the questionnaire: physical wellbeing subscale, family/social wellbeing subscale, emotional well-being subscale, functional well-being subscale and a colorectal cancer-specific subscale. The TOI combines the physical, functional and cancer-specific subscales, which are considered likely to change by an intervention being tested. Scale range (minimum and maximum scores): 0-84 Which values are considered to be a better or worse outcome: The higher the score, the better the QOL. Indicate how subscales are combined (summed, averaged etc.): The TOI is calculated by summing the scores from the physical, functional and colorectal cancer-specific subscales.
次要结局
- Bowel Function for patients without a stoma(Measured at 3 years after primary surgery)
- Patient information and sense of security(Measured at 3 years after primary surgery)
- Cost-benefit - QALY's(Measured at 1 year after primary surgery)
- Fatigue(Measured at 3 years after primary surgery)
- Psychological Distress(Measured at 3 years after primary surgery.)
- Self-efficacy(Measured at 3 years after primary surgery)
- Sexual Function for males(Measured at 3 years after primary surgery)
- Chronic pain(Measured at 3 years after primary surgery)
- Fear of Cancer Recurrence(Measured at 3 years after primary surgery)
- Patient involvement(Measured at 3 years after primary surgery)
- Bowel Function for patients without a stoma - shape and type of the stool(Measured at 3 years after primary surgery)
- Urinary Function(Measured at 3 years after primary surgery)
- Stoma Function for patient with a colonostomy(Measured at 3 years after primary surgery)
- Sexual Function for females(Measured at 3 years after primary surgery)
研究者
Ida Hovdenak Jakobsen
PhD-student, registered nurse
Aarhus University Hospital